CN114450064A

CN114450064A - Irradiation apparatus and treatment method

Info

Publication number: CN114450064A
Application number: CN202080068143.XA
Authority: CN
Inventors: 秦真由; 大津惠子; 末原达
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2019-09-30
Filing date: 2020-09-30
Publication date: 2022-05-06
Also published as: US20220219009A1; JPWO2021066012A1; WO2021066012A1

Abstract

The present invention provides an irradiation instrument and a treatment method capable of effectively irradiating near-infrared light to an antibody-photosensitive substance bound to a cell membrane of cervical cancer. It is a method of treatment of cervical cancer having: a step of administering the antibody-light absorbing substance intravenously; inserting an irradiation instrument (10) having an optical fiber (60) and a position confirmation mark (50) into a Uterine Artery (UA) 12 to 36 hours after intravenous administration; irradiating near-infrared light in a direction substantially perpendicular to the optical fiber (60) by using the optical fiber (60); inserting an irradiation instrument (10) into the cervical region (U) from the vagina (V); irradiating the optical fiber (60) of the irradiation instrument (10) in a direction substantially perpendicular to the optical fiber (60); a step of pulling out a balloon (30) of an irradiation instrument (10) to the external cervical os (O) and inflating the balloon (30) so as to follow the shape of the organ; irradiating near-infrared light with an optical fiber (60) in a direction substantially toward the tip and/or in a direction substantially perpendicular to the optical fiber (60).

Description

Irradiation apparatus and treatment method

Technical Field

The invention relates to an irradiation instrument for treating cervical cancer and a treatment method of the cervical cancer.

Background

Patients with cervical cancer are increasing, particularly patients with young women in their 20-30 + years old. In the current treatment of cervical cancer, the entire uterus is removed at an early stage (stage I) as a standard treatment, but for younger patients, a local treatment capable of preserving the uterus is required to maintain fertility. In addition, in the advanced stage (after stage III), since cancer spreads to surrounding tissues and is difficult to be removed by surgery, a treatment combining radiotherapy and chemotherapy is used as a standard treatment. However, 5-year survival rates are 50% during phase III and as low as 20% during phase IV, requiring more effective treatment. As a local treatment of cancer, a treatment method using a photoreactive substance is known. Among them, a therapeutic method using an antibody-photosensitizing substance (hydrophilic phthalocyanine dye) is expected to reduce side effects and obtain a high therapeutic effect by irradiating near-infrared light to the antibody-photosensitizing substance accumulated in a tumor, thereby specifically killing target cells without killing non-target cells such as normal cells.

Documents of the prior art

Patent document

Patent document 1: specification of U.S. patent application publication No. 2018-0113246

Disclosure of Invention

Problems to be solved by the invention

On the other hand, in order to obtain a high therapeutic effect of the antibody-photosensitive substance, it is necessary to reliably irradiate near-infrared light to the antibody-photosensitive substance adsorbed to the tumor. However, the depth of invasion of near-infrared light is shallow, and it is very difficult for light to reach solid cancer from the body surface noninvasively. Therefore, means for reliably allowing light to reach a tumor in vivo while suppressing the invasiveness as much as possible is required. In the case of cervical cancer, cancer has spread in a wide range of the cervical canal in many cases, and means for irradiating a wide range of cancer with light from the near side is required as much as possible. In addition, depending on the stage of progression, cancer may reach the pelvic wall, and at this time, the pelvic wall is difficult to be reached by a minimally invasive method using a vagina, a laparoscope, or the like. For example, patent document 1 discloses a method of inserting a long instrument provided with an optical fiber into the vicinity of a tumor via a blood vessel and irradiating the blood vessel with light.

The present invention has been made to solve the above-mentioned problems, and an object thereof is to provide an irradiation instrument and a treatment method capable of efficiently irradiating near-infrared light to an antibody-photosensitizer bound to a cell membrane of cervical cancer.

Means for solving the problems

One embodiment of the therapeutic method of the present invention for achieving the above object is a therapeutic method for cervical cancer, comprising: a step of administering the antibody-light absorbing substance intravenously; inserting a first irradiation instrument having a first optical fiber and a position confirmation mark into a uterine artery 12 to 36 hours after the intravenous administration; confirming the position of the first irradiation instrument by using the position confirmation mark and advancing the first irradiation instrument to a target position; irradiating near-infrared light in a direction substantially perpendicular to the first optical fiber by using the first optical fiber; a step of pulling out the first irradiation instrument from the body; inserting the first irradiation device or a second irradiation device serving as another irradiation device into the cervical part from the vagina; irradiating the second optical fiber of the second irradiation instrument in a direction substantially perpendicular to the second optical fiber; a step of pulling out at least a part of the deformed portion of the second irradiation instrument to the external cervical os to expand the deformed portion so as to follow the shape of the organ; irradiating near-infrared light in a direction substantially perpendicular to the second optical fiber and/or in a direction substantially perpendicular to the second optical fiber by using the second optical fiber; and contracting the deformation portion.

ADVANTAGEOUS EFFECTS OF INVENTION

In the treatment method configured as described above, the first irradiation instrument is inserted into the uterine artery, and the near-infrared light is irradiated from the inside of the blood vessel in a substantially vertical direction, so that the tissue or organ infiltrated with cancer cells in the vicinity of the uterine artery can be effectively irradiated with the near-infrared light. In addition, according to the treatment method, the second irradiation instrument is inserted into the cervical part and irradiates near infrared light in a substantially vertical direction, so that the near infrared light can be effectively irradiated to the cancer cells in the cervical part from the inner cavity of the cervical part. Furthermore, the treatment method expands the deformed portion pulled out from the external cervical os and irradiates near-infrared light in the distal direction and/or the vertical direction, so that it is possible to effectively irradiate near-infrared light to cancer cells in the vicinity of the cervicovaginal region. Therefore, the present treatment method can effectively irradiate near infrared light to the antibody-photosensitive substance bound to the cell membrane of cervical cancer.

Another embodiment of the therapeutic method of the present invention for achieving the above object is a therapeutic method for cervical cancer, which may further comprise: a step of administering the antibody-light absorbing substance intravenously; inserting a first irradiation instrument having a first optical fiber and a position confirmation mark into a uterine artery 12 to 36 hours after the intravenous administration; confirming the position of the first irradiation instrument by using the position confirmation mark and advancing the first irradiation instrument to a target position; irradiating near-infrared light in a direction substantially perpendicular to the first optical fiber by using the first optical fiber; a step of pulling out the first irradiation instrument from the body; inserting the first irradiation device or a second irradiation device serving as another irradiation device into the cervical part from the vagina; a step of expanding the deformed portion of the second irradiation instrument so as to follow the shape of the organ; irradiating near-infrared light in a direction substantially perpendicular to the second optical fiber and/or in a direction substantially perpendicular to the second optical fiber by using the second optical fiber; and contracting the deformation portion.

In the treatment method configured as described above, the first irradiation instrument is inserted into the uterine artery, and the near-infrared light is irradiated from the inside of the blood vessel in a substantially vertical direction, so that the tissue or organ infiltrated with cancer cells in the vicinity of the uterine artery can be effectively irradiated with the near-infrared light. In addition, according to the treatment method, the second irradiation instrument is inserted into the cervical part, the deformation part is expanded, and the near infrared light is irradiated in the distal direction and/or the vertical direction, so that the near infrared light can be effectively irradiated to a wide range of cervical cancer of the cervical part. Therefore, the present treatment method can effectively irradiate near infrared light to the antibody-photosensitive substance bound to the cell membrane of cervical cancer.

Another mode of the therapeutic method of the present invention for achieving the above object is a therapeutic method for cervical cancer, which may further comprise: a step of administering the antibody-light absorbing substance intravenously; inserting a second irradiation instrument having a second optical fiber into the cervical region from the vagina after 12 to 36 hours from the intravenous administration; irradiating the second optical fiber of the second irradiation instrument in a direction substantially perpendicular to the second optical fiber; a step of pulling out at least a part of the deformed portion of the second irradiation instrument to the external cervical os to expand the deformed portion so as to follow the shape of the organ; irradiating near-infrared light in a direction substantially perpendicular to the optical fiber and/or in a direction substantially toward the distal end of the optical fiber by using the second optical fiber; and contracting the deformation portion.

In the treatment method configured as described above, the second irradiation instrument is inserted into the cervical part and irradiates near-infrared light in a substantially vertical direction, and therefore, the cancer cells in the cervical part can be effectively irradiated with near-infrared light from the inner cavity of the cervical part. Furthermore, the treatment method expands the deformed portion pulled out from the external cervical os and irradiates near-infrared light in the distal direction and/or the vertical direction, so that it is possible to effectively irradiate near-infrared light to cancer cells in the vicinity of the cervicovaginal region. Therefore, the treatment method can effectively irradiate the near infrared light to the cervix uteri and the antibody-photosensitive substance combined with the cell membrane of the cancer cell of the tissues and organs infiltrated from the cervix uteri in the up-down direction.

Another mode of the therapeutic method of the present invention for achieving the above object is a therapeutic method for cervical cancer, which may further comprise: a step of administering the antibody-light absorbing substance intravenously; inserting a second irradiation instrument having a second optical fiber into the cervical region from the vagina after 12 to 36 hours from the intravenous administration; a step of expanding the deformed portion of the second irradiation instrument so as to follow the shape of the organ; irradiating near-infrared light in a direction substantially perpendicular to the optical fiber and/or in a direction substantially toward the distal end of the optical fiber by using the second optical fiber; and contracting the deformation portion.

In the treatment method configured as described above, the second irradiation instrument is inserted into the cervical canal to expand the deformed portion, and near-infrared light is irradiated in the distal direction and/or the vertical direction, so that near-infrared light can be effectively irradiated to a wide range of cancer cells in the cervical region. Therefore, the treatment method can effectively irradiate the near infrared light to the cervix uteri and the antibody-photosensitive substance combined with the cell membrane of the cancer cell of the tissues and organs infiltrated from the cervix uteri in the up-down direction.

In the step of expanding the deformation portion in the treatment method, a part of the deformation portion may be expanded so as to follow the shape of the cervicovaginal portion on the proximal end side with respect to the external cervical os. Thus, the treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cells of the cervical part including the cervicovaginal part and the tissues and organs infiltrated below the cervical part.

In the step of expanding the deformation portion in the treatment method, the proximal end portion of the deformation portion may be expanded so as to follow the shape of the cervicovaginal portion on the proximal side of the external cervical os, and the distal end portion of the deformation portion may be expanded so as to follow the shape of the uterine cavity on the distal side of the internal cervical os. Therefore, the treatment method can effectively irradiate the near infrared light to the antibody-photosensitive substance combined with the cell membranes of the cervical part and the cancer cells of tissues and organs infiltrated from the cervical part in the up-down direction.

The treatment method may be such that, after the step of contracting the deformed portion, the following steps are repeated at least 1 time: rotating the second irradiation instrument; expanding the deformation portion so as to follow the shape of the organ; irradiating near infrared light toward the front end direction and/or the direction perpendicular to the second optical fiber by using the second optical fiber; and contracting the deformation portion. Thus, the treatment method can irradiate near-infrared light in a wide range in the circumferential direction of the cervix uteri.

The second irradiation device may be the same as the first irradiation device. Thus, the treatment method can perform irradiation of near-infrared light from the uterine artery and irradiation of near-infrared light from the cervical part with 1 irradiation instrument. Therefore, the treatment method can improve medical economy.

In the treatment method, the first irradiation instrument may be cleaned after the step of pulling out the first irradiation instrument from the body. Thus, the treatment method can remove blood adhering to the first irradiation device inserted into the blood vessel, and can bring the first irradiation device into an ideal state for insertion from the vagina into the cervix.

The treatment method may also have: expanding a deformed portion of the first irradiation instrument before the step of irradiating near-infrared light with the first optical fiber; and a step of contracting the deformed portion of the first irradiation instrument after the step of irradiating near-infrared light with the first optical fiber. Thus, when the first irradiation device in the uterine artery is irradiated with near-infrared light, the blood flow in the uterine artery can be blocked. Therefore, the influence of blood on the near-infrared light can be reduced, and the target region can be effectively irradiated with the near-infrared light.

An irradiation instrument according to the present invention for achieving the above object is an irradiation instrument for treating cervical cancer, comprising: the balloon light source includes an elongated shaft portion, an expandable balloon provided at a distal end portion of the shaft portion, an optical fiber, and an irradiation portion provided at a distal end of the optical fiber and disposed inside the balloon and capable of irradiating light, wherein the irradiation portion is capable of irradiating light in a direction substantially perpendicular to an axis of the optical fiber and in a direction substantially toward the distal end.

The irradiation unit may irradiate light in a contracted state and an expanded state of the balloon.

The balloon may have a position confirmation mark that is opaque to X-rays inside.

The position confirmation mark may have a structure that stores light, a structure that emits fluorescence, or a structure that transmits light.

Drawings

Fig. 1 is a plan view showing an irradiation instrument used in the treatment method of the first embodiment.

FIG. 2 is a sectional view showing the distal end portion of the irradiation instrument.

FIG. 3 is a schematic view showing a state in a body when an irradiation instrument is inserted into a uterine artery in the treatment method according to the first embodiment.

FIG. 4 is a schematic cross-sectional view for explaining a state in which near-infrared light is irradiated by an irradiation instrument inserted into a uterine artery.

FIG. 5 is a schematic view showing an irradiation instrument inserted into the cervical part from the vagina, (A) shows a state where near-infrared light is irradiated from the cervical part; (B) the deformed portion pulled out to the external cervical os is deformed to emit near-infrared light.

FIG. 6 is a schematic view showing a state where near-infrared light is irradiated by an irradiation instrument inserted into the cervical region from the vagina in the treatment method of the second embodiment.

FIG. 7 is a plan view showing a first modification of the irradiation instrument, wherein (A) shows a state before a deformation portion is deformed; (B) the state after the deformation of the deformation portion is shown.

FIG. 8 is a plan view showing a second modification of the irradiation instrument, wherein (A) shows a state before the deformation portion is deformed; (B) the deformed portion is shown in a deformed state.

FIG. 9 is a plan view showing a third modification of the irradiation instrument, wherein (A) shows a state before the deformation portion is deformed; (B) the deformed portion is shown in a deformed state.

Detailed Description

Hereinafter, embodiments of the present invention will be described with reference to the drawings. It should be noted that the size of the drawings is exaggerated from the actual size for convenience of explanation. In the present specification and the drawings, the same reference numerals are given to the constituent elements having substantially the same functional configurations, and the redundant description thereof is omitted. In the present specification, the side of the instrument inserted into the living body lumen is referred to as the "distal side", and the side to be operated is referred to as the "proximal side".

< first embodiment >

The treatment method of the first embodiment is a treatment method of cervical cancer, which is a treatment method of photoimmunotherapy involving irradiating near-infrared light to an antibody-photosensitive substance bound to a cell membrane of a cancer cell to kill the cancer cell. The therapeutic method uses, as a drug, an antibody-photosensitizer which is formed by binding an antibody specifically binding only to a specific antigen located on the surface of a cancer cell and a photosensitizer which is a partner of the antibody. The antibody is not particularly limited, and examples thereof include Panitumumab (Japanese: パ bis ツムバブ; Panitumumab), Trastuzumab (Trastuzumab), and HuJ 591. The photosensitive substance is, for example, a hydrophilic phthalocyanine dye, which is a substance that reacts with near infrared light having a wavelength of about 700nm (IR700), but is not limited thereto. IR700 absorbs light when it receives near-infrared light having a wavelength with a peak at around 700nm, and chemically changes to form pores in the cell membrane, thereby killing cancer cells.

In the treatment method of the first embodiment, an irradiation instrument 10 insertable into a blood vessel and a cervical part as shown in fig. 1 is used to irradiate near-infrared light to the antibody-photosensitive substance bound to cancer cells through the blood vessel and the vagina. The irradiation instrument 10 will be explained first.

As shown in fig. 1 and 2, the irradiation instrument 10 includes an elongated shaft portion 20, a balloon 30 as a deformable portion provided at a distal end portion of the shaft portion 20, a hub portion 40 connected to a vicinity of the shaft portion 20, a position confirmation mark 50, and an optical fiber 60. The irradiation instrument 10 is connected to a light output device 70 for use.

The shaft portion 20 includes an outer tube 21 as a tubular body having open distal and proximal ends, and an inner tube 22 disposed inside the outer tube 21. An expansion lumen 23 through which an expansion fluid for expanding the balloon 30 flows is formed between the outer tube 21 and the inner tube 22, and a guide wire lumen 24 into which a guide wire 80 can be inserted is formed inside the inner tube 22.

The balloon 30 has a distal end bonded to the inner tube 22 and a proximal end bonded to the outer tube 21, and the balloon 30 communicates with the inflation lumen 23. The balloon 30 can be deformed and inflated by flowing a fluid into the inside.

The hub portion 40 includes a first opening 41 communicating with the dilating lumen 23 of the outer tube 21 and functioning as a port through which a dilating fluid flows in and out, a second opening 42 communicating with the guidewire lumen 24, and a connection cable 43 for connecting the optical fiber 60 to the light output device 70. The connection cable 43 is attachable/detachable with respect to the light output device 70.

The balloon 30 is preferably formed of a material having a certain degree of flexibility, and examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, and a mixture of two or more of the above, soft polyvinyl chloride resins, thermoplastic resins such as polyamide, polyamide elastomer, polyester elastomer, polyurethane, and fluorine resin, silicone rubber, and latex rubber.

The light output device 70 can output near-infrared light of an arbitrary wavelength to the optical fiber 60 at an arbitrary dose. The light output device 70 can have a wavelength of 660 to 740nm, for example, 1 to 50Jcm^-2The light is output to the optical fiber 60 in such a manner that the dose of light is irradiated.

The optical fiber 60 extends within the inflation lumen 23 along the outer surface of the inner tube 22 from the hub 40 to the balloon 30. The optical fiber 60 may be constituted by 1 fiber or a plurality of fibers bundled together. The optical fiber 60 can receive near-infrared light from the light output device 70 through the connection cable 43 provided to the hub portion 40. The distal end of the optical fiber 60 is provided with an irradiation unit 61 for irradiating light.

The irradiation section 61 irradiates light entering from the base end side of the optical fiber 60 to the outside. The irradiation unit 61 may be configured by using a lens, a diffuser, a mirror, or the like, for example. The irradiation section 61 is appropriately designed so as to irradiate near-infrared light in a predetermined direction using a lens, a diffuser, a mirror, or the like. The structure of the irradiation unit 61 is not limited as long as the irradiation unit can irradiate light to the outside.

The irradiation portion 61 irradiates near-infrared light from the inside of the balloon 30 to a range including both a direction substantially perpendicular to the axis of the optical fiber 60 and a direction substantially at the distal end (a direction parallel to the axis of the optical fiber 60). Therefore, the near-infrared light can be irradiated at a predetermined irradiation angle. Alternatively, the irradiation unit 61 may irradiate near-infrared light only in any direction of a direction substantially perpendicular to the axis of the optical fiber 60 or a direction substantially at the distal end thereof.

The position confirmation mark 50 is a site for the operator to confirm the position in the body. The position confirmation mark 50 is disposed in the vicinity of the balloon 30 and the irradiation portion 61. The positions where the position confirmation marks 50 are arranged and the number of the position confirmation marks 50 are not particularly limited, and the position confirmation marks 50 may be arranged at two positions on the outer peripheral surface of the inner tube 22 inside the balloon 30, for example. The position confirmation mark 50 may be disposed on the outer tube 21, for example. The position confirmation mark 50 can be formed using, for example, a material that is opaque to X-rays. Examples of the material opaque to X-rays include metals such as gold, platinum, and tungsten, and metal materials such as alloys containing the above metals. This enables the operator to confirm the position of the position confirmation marker 50 by X-ray contrast outside the body. The position confirmation mark 50 may not be a marker for X-ray contrast as long as the operator can confirm the position in the body. Therefore, the position confirmation mark 50 can be used for position confirmation of the portion inserted into the cervical part U. The position confirmation marker 50 may function as a marker that allows the position to be confirmed by X-rays when inserted into a blood vessel, or may function as a marker that allows the position to be confirmed by X-rays, ultrasonic waves, or the like when inserted into the cervical region U. The position confirmation mark 50 may be a light accumulating type mark containing a material capable of accumulating light, for example. The position confirmation mark 50 can emit light stored in advance. Alternatively, the position confirmation mark 50 may be a fluorescent mark. The fluorescent marker emitting fluorescence can be excited by irradiation light from the optical fiber 60 and/or the irradiation portion 61, or other optical fiber capable of irradiating light inserted into the guide wire lumen 24, and emit fluorescence of a different wavelength. The operator can observe the light emission state of the irradiation apparatus through a filter that transmits only a specific wavelength or a filter that can cut off the wavelength of the irradiation light, and thereby perform positioning of the irradiation apparatus 10 before treatment and confirmation of the position of the irradiation apparatus 10 during irradiation for treatment. Alternatively, the position confirmation mark 50 may be a light-transmitting mark including a transparent portion through which light from the inside of the shaft portion 20 can be transmitted. In this case, the position confirmation mark 50 may be disposed so as to cover a hole penetrating from the inner peripheral surface to the outer peripheral surface of the shaft portion 20, or may be disposed inside the hole. The position confirmation mark 50 can transmit light emitted from a device such as another optical fiber that is inserted into the guide lumen 24 of the shaft portion 20 and can emit the light to the outside. The operator can observe the light emitted from the position confirmation mark 50 of the light storage type, the fluorescence type, or the light transmission type, using, for example, a colposcope inserted into the vagina V.

Next, a treatment method according to the first embodiment will be described.

First, the antibody-photosensitizing substance was administered intravenously. After about 12 to 36 hours from the intravenous administration, the operator inserts the guidewire 80 into the blood vessel, for example, from the femoral artery, as shown in fig. 3. Next, the proximal end of the guide wire 80 is inserted into the guide wire lumen 24 of the irradiation instrument 10, and the irradiation instrument 10 is passed through the internal iliac artery along the guide wire 80 to reach the uterine artery UA. Next, the operator confirms the position of the position confirmation mark 50 under X-ray contrast, and moves the distal end portion of the irradiation instrument 10 (particularly, the irradiation portion 61) from the cervical part U to the vicinity of the tissue or organ in which the cancer cells C infiltrate. The tissue and organ with cancer cells C are cervical part, periuterine tissue, pelvis, bladder wall and rectal mucosa. The operator places the distal end portion of the irradiation instrument 10 at a position where the near-infrared light can be irradiated to the tissue or organ infiltrated with the cancer cells C.

Next, as shown in fig. 4, near infrared light is irradiated from the optical fiber 60. The irradiation with near-infrared light is started 12 to 36 hours after the intravenous administration. The irradiation direction of the near-infrared light from the optical fiber 60 includes a direction perpendicular to the axis of the optical fiber 60. Therefore, the optical fiber 60 can effectively irradiate the near-infrared light from the inside of the blood vessel to the portion outside the blood vessel. The optical fiber 60 may be irradiated with near infrared light in the distal direction. The operator can appropriately select the optical fiber 60 to be used according to the position of the cancer cell C with respect to the blood vessel into which the irradiation instrument 10 is inserted.

The operator may supply the physiological saline from the proximal end side of the irradiation instrument 10 to the guidewire lumen 24 before irradiating the near-infrared light by the optical fiber 60. Thereby, the saline is injected from the irradiation instrument 10 into the uterine artery UA (irrigation). As a result, blood in the blood vessel in which the distal end portion of the irradiation instrument 10 is located is washed away, and irradiation of near-infrared light can be made less susceptible to blood. Before the near-infrared light is irradiated from the optical fiber 60, the operator may supply an inflation fluid from the inflation lumen 23 into the balloon 30 to inflate the balloon 30. The balloon 30 adheres to the vessel wall to block blood flow. This makes it possible to prevent blood from being present between the balloon 30 and the blood vessel wall, and thus irradiation with near infrared light can be made less likely to be affected by blood. When the operator inflates the balloon 30, after irradiation of the near infrared light is completed, the operator discharges the fluid for expansion from the balloon 30 to deflate the balloon 30.

When near-infrared light is irradiated, the near-infrared light reaches the antibody-photosensitive substance bound to the cell membrane of the cancer cell C. Thereby, a chemical change of the photosensitizing substance occurs, and a structural change of the antibody-photosensitizing substance is caused, whereby a hole can be formed in the cell membrane, and the cancer cell C can be killed.

When the operator determines that the cancer cells C have been sufficiently killed, determines that further irradiation is not desired, or when a predetermined time has elapsed, the irradiation with near infrared light is stopped.

Next, the operator pulls the irradiation instrument 10 out of the body. Next, the operator cleans the irradiation instrument 10. Thereby, blood is removed from the irradiation instrument 10. It is preferable that the blood vessel into which the irradiation instrument 10 is inserted is not infiltrated with the cancer cells C. Thus, the irradiation device 10 does not have cancer cells C attached thereto, and the same irradiation device 10 can be used for the subsequent vaginal treatment.

Next, the operator identifies the position of the cancer cell C irradiated with the near infrared ray and records the position. It is desirable to record the position of the cancer cell C as electronic data so as to correspond to positional information of data such as a CT image and an MRI image of a patient obtained in advance. This enables the subsequent operations to be smoothly performed and enables the post-operation follow-up to be effectively performed. For example, when near-infrared radiation is applied to a plurality of cancer cells C, the tumor C to which the near-infrared radiation has been applied can be accurately grasped, and the irradiation of all the cancer cells C can be smoothly and reliably performed. The position of the cancer cell C can be appropriately determined and recorded even in the next irradiation with near infrared rays.

Next, as shown in fig. 5 (a), the operator inserts the irradiation instrument 10 pulled out and washed from the blood vessel into the cervical canal CC of the cervical part U from the vagina V through the external cervical os O. Thus, the balloon 30 is positioned in the cervical canal CC. Next, the operator irradiates near infrared light through the optical fiber 60. The irradiation direction of the near-infrared light from the optical fiber 60 includes a direction substantially perpendicular to the axis of the optical fiber 60. Therefore, the optical fiber 60 can effectively irradiate near-infrared light from the cervical canal CC to the cancer cells C located in the cervical part U. The optical fiber 60 may be irradiated with near infrared light in the distal direction. The operator may insert the irradiation instrument 10, which is different from the irradiation instrument 10 pulled out from the blood vessel and washed, into the cervical canal CC from the vagina V. When the near-infrared light is irradiated from the cervical canal CC, the distal end of the irradiation instrument 10 is in close contact with the cervical part U because the cervical canal CC is narrowed. Thus, inflation of balloon 30 is not required. The balloon 30 may be inflated in the inner cavity of the cervical portion U.

When the near-infrared light is irradiated, the near-infrared light reaches the antibody-photosensitive substance bound to the cell membrane of the cancer cell C in the cervical part U. Thereby, chemical change of the light-sensitive substance occurs, and structural change of the antibody-light-sensitive substance is caused, so that a hole is formed in the cell membrane, and the cancer cell C of the cervical part U irradiated with the infrared light is killed.

Next, the operator pulls the irradiation instrument 10 to pull out at least a part (or all) of the balloon 30 and the irradiation portion 61 from the external cervical os O. Then, an inflation fluid is supplied into the balloon 30 from the inflation lumen 23, and the balloon 30 is inflated as shown in fig. 5 (B). Next, the operator delivers the irradiation instrument 10 with the tip end of the inflated balloon 30 against the cervicovaginal region UV. The cervix and vagina portion UV is a portion of the cervix U on the vagina V side, and a cervix external os is formed. Therefore, the balloon 30 is closely attached to the vicinity of the external cervical os O of the cervicovaginal region UV, and is inflated so as to follow the shape of the cervicovaginal region UV (organ). When a part of the balloon 30 is positioned in the cervical canal CC, the balloon 30 can be kept in close contact with the vicinity of the external cervical os O of the cervicovaginal area UV even if the operator does not deliver the irradiation instrument 10.

Next, the operator irradiates near infrared light through the optical fiber 60. The irradiation direction of the near-infrared light from the optical fiber 60 includes a direction substantially in the front end and/or a direction substantially perpendicular to the axis of the optical fiber 60. The near-infrared light irradiated from the optical fiber 60 in the distal direction can effectively reach the cancer cells C located in the cervico-vaginal UV region. Near-infrared light irradiated from the optical fiber 60 in a direction perpendicular to the axis of the optical fiber 60 can reach the cancer cells C in the portion of the external cervical os O distant from the cervicovaginal region UV from a direction different from the irradiation in fig. 5 (a), and can effectively reach the cancer cells C in the vagina V. Therefore, the optical fiber 60 can effectively irradiate near-infrared light to the cancer cells C located in the cervicovaginal region UV and the vagina V.

When the operator determines that the cancer cells C have been sufficiently killed, determines that further irradiation is not desired, or when a predetermined time has elapsed, the irradiation with near infrared light is stopped. Next, the operator discharges the fluid for expansion from the balloon 30 to deflate the balloon 30.

Then, the operator rotates the irradiation instrument 10 by a predetermined angle around the axial center of the irradiation instrument 10. The angle of rotation is not particularly limited, and is, for example, 90 ° to 180 °. Then, the operator inflates the balloon 30 again in the same manner as described above, and brings the balloon 30 into close contact with the vicinity of the external cervical os O of the cervicovaginal region UV. The balloon 30 is inflated so as to follow the shape of the cervicovaginal region UV (organ). Then, the operator irradiates near infrared light through the optical fiber 60. Thus, near-infrared light is irradiated to a different site from that before the rotation, thereby irradiating near-infrared light to cancer cells C at different positions in the cervicovaginal region UV and the vagina V. Then, the operator stops the irradiation of the near infrared light. A series of steps combining the rotation of the irradiation instrument 10, the inflation of the balloon 30, the irradiation with near infrared light, the stop of irradiation, and the contraction of the balloon 30 can be repeated 1 or more times. The series of steps may not be performed at once. The operator then pulls the irradiation instrument 10 out of the body. Thus, the present treatment method was completed.

Even during the operation, the operator can confirm the position of the position confirmation mark 50 by X-ray or ultrasonic wave and position the irradiation instrument 10 at the target position of the cervical region U. When the position confirmation mark 50 is a light-storing or light-transmitting mark, the operator can observe the light emitted from the position confirmation mark 50 from the vaginal V side through a colposcope or the like and insert the irradiation instrument 10 from the vaginal V into the cervical part U. The operator cannot observe the light to recognize that the portion of the irradiation instrument 10 where the position confirmation mark 50 is provided has been inserted into the cervical canal CC of the cervical part U from the vagina V. Therefore, the position confirmation mark 50 can function as a positioning mechanism for accurately positioning the irradiation instrument 10 so that a part of the irradiation instrument 10 is inserted into the cervical canal CC.

The operator can also check the light emitted from the position confirmation mark 50 from the vaginal V side through a colposcope or the like and pull out the irradiation instrument 10 inserted into the cervical part U from the cervical part U to the vaginal V side. The operator can observe the light to recognize that the position confirmation mark 50 of the irradiation instrument 10 has been pulled out from the cervical part U to the vaginal part V. Therefore, the position confirmation mark 50 can function as a positioning mechanism for accurately positioning the irradiation instrument 10 so that a part of the irradiation instrument 10 is inserted into the cervical canal CC. When the operator repeatedly inserts and withdraws the cervical part U, the light emitted from the position confirmation mark 50 is observed from the vaginal V side during each operation, and the irradiation instrument 10 can be accurately positioned.

As described above, the treatment method of the first embodiment is a treatment method of cervical cancer, which has: a step of administering the antibody-light absorbing substance intravenously; inserting a first irradiation instrument 10 having a first optical fiber 60 and a position confirmation mark 50 into a uterine artery UA 12 to 36 hours after intravenous administration; a step of confirming the position of the first irradiation instrument 10 by using the position confirmation mark 50 and advancing the irradiation instrument 10 toward the target position; irradiating near-infrared light in a direction substantially perpendicular to the first optical fiber 60 by using the first optical fiber 60; a step of pulling out the first irradiation instrument 10 from the body; a step of inserting the first irradiation apparatus 10 or a second irradiation apparatus 10 as another irradiation apparatus 10 into the cervical part U from the vagina V; irradiating the second optical fiber 60 of the second irradiation instrument 10 in a direction substantially perpendicular to the second optical fiber 60; a step of pulling out at least a part of the deformed portion of the second irradiation instrument 10 to the external cervical os O and inflating the balloon 30 as the deformed portion so as to follow the shape of the organ; irradiating the near-infrared light with the second optical fiber 60 in a direction substantially toward the distal end and/or in a direction substantially perpendicular to the optical fiber 60; a step of deflating the balloon 30.

In the treatment method configured as described above, the first irradiation instrument 10 is inserted into the uterine artery UA and near-infrared light is irradiated from the inside of the blood vessel in a substantially vertical direction, and therefore, near-infrared light can be effectively irradiated to the tissue or organ infiltrated with the cancer cells C in the vicinity of the uterine artery UA. In the treatment method, the second irradiation instrument 10 is inserted into the narrow cervical canal CC and the near-infrared light is irradiated in the substantially vertical direction, so that the near-infrared light can be effectively irradiated from the cervical canal CC of the cervical part U to the cancer cells C of the cervical part U. Further, in the present treatment method, the balloon 30 as the deformed portion pulled out from the external cervical os O is inflated and near-infrared light is irradiated in the distal direction and/or the vertical direction, so that near-infrared light can be effectively irradiated to cervical cancer in the vicinity of the cervicovaginal region UV. Therefore, the treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cell C in the cervical region U and the cancer cell C of the tissue or organ infiltrated from the cervical region U. The treatment method is effective not only in the early stage when cancer cells C are localized in the cervical region, but also in stage IIB when cancer cells C infiltrate into the parauterine tissue, stage IIIA when the infiltration of the vaginal wall reaches 1/3 of the lower part of the vagina, stage IIIB when infiltration into the parauterine tissue reaches the pelvic wall, and stage IVA when cancer cells C infiltrate into the urinary bladder and rectal mucosa.

In the treatment method, after the step of deflating the balloon 30 as the deformed portion, the following steps may be repeated at least 1 time: a step of rotating the second irradiation instrument 10; a step of inflating the balloon 30 so as to follow the shape of the organ; irradiating the near-infrared light with the second optical fiber 60 in a direction substantially toward the distal end and/or in a direction substantially perpendicular to the second optical fiber 60; a step of deflating the balloon 30. Thus, the treatment method can irradiate near-infrared light in a wide range in the circumferential direction of the cervical part U. In addition, the present treatment method can irradiate near-infrared light over a wide range in the circumferential direction of the vagina V.

In addition, the second irradiation instrument 10 is the same as the first irradiation instrument 10. Thus, the treatment method can perform irradiation of near-infrared light from the uterine artery UA and irradiation of near-infrared light from the cervical part U with 1 irradiation instrument 10. Therefore, the treatment method can improve medical economy. The second irradiation apparatus 10 may not be the same as the first irradiation apparatus 10.

In addition, the treatment method cleans the first irradiation instrument 10 after the step of pulling the first irradiation instrument 10 out of the body. Thus, the treatment method can remove blood adhering to the first irradiation device 10 inserted into the blood vessel, and can bring the first irradiation device 10 into an ideal state for insertion from the vagina V into the cervical part U.

In addition, the treatment method may further include: before the step of irradiating the near-infrared light with the first optical fiber 60, a step of inflating the balloon 30 provided in the first irradiation device 10; after the step of irradiating the near-infrared light with the first optical fiber 60, the balloon 30 of the first irradiation device 10 is deflated. Thus, when the first irradiation device 10 in the uterine artery UA irradiates the near-infrared light, the blood flow in the uterine artery UA can be blocked. Therefore, the influence of blood on the near-infrared light can be reduced, and the target region can be effectively irradiated with the near-infrared light.

In addition, in the first embodiment, the therapeutic device may not be inserted into the blood vessel. That is, a modification of the treatment method of the first embodiment is a treatment method for cervical cancer, comprising the step of intravenously administering an antibody-light-absorbing substance; inserting a second irradiation device 10 having a second optical fiber 60 into the cervical region U from the vagina V after 12 to 36 hours from the intravenous administration; irradiating the second optical fiber 60 of the second irradiation instrument 10 in a direction substantially perpendicular to the second optical fiber 60; a step of pulling out at least a part of the balloon 30 of the second irradiation instrument 10 to the external cervical os O and inflating the balloon 30 so as to follow the shape of the organ; irradiating the near-infrared light with the second optical fiber 60 in a direction substantially toward the distal end and/or in a direction substantially perpendicular to the second optical fiber 60; a step of deflating the balloon 30.

In the treatment method configured as described above, the irradiation instrument 10 is inserted into the small cervical part U, the balloon 30 is inflated, and the near-infrared light is irradiated in the distal direction and/or the vertical direction, so that the near-infrared light can be effectively irradiated to a wide range of cervical cancer in the cervical part U. Therefore, the treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cell C in the cervical region U. The treatment method is effective not only in the early stage where cancer cells C are localized in the cervical part of the uterus, but also in the stage IIA and stage IIIA where cancer cells C infiltrate into the vaginal wall.

< second embodiment >

The treatment method of the second embodiment is a method of inserting the irradiation instrument 10 from the vagina V into the cervical part U, and is different from the treatment method of the first embodiment. The irradiation instrument 10 used is the same as the irradiation instrument 10 used in the treatment method of the first embodiment.

In the treatment method according to the second embodiment, the operator inserts the irradiation instrument 10 into the uterine artery UA in the same manner as in the first embodiment, and irradiates the tissue or organ infiltrated with the cancer cells C with the near-infrared light from the inside of the uterine artery UA.

After the operator pulls the irradiation instrument 10 out of the blood vessel and washes it, the operator inserts the cervical canal CC from the vagina V through the external cervical os O as shown in fig. 6. Thus, the distal end portion of the balloon 30 is disposed in the uterine cavity UC on the distal side of the internal cervical os I, and the proximal end portion of the balloon 30 is disposed in the vagina V on the proximal side of the external cervical os O. Thus, the balloon 30 extends through the cervical canal CC. Next, the operator irradiates near infrared light through the optical fiber 60. Thus, the optical fiber 60 disposed in the cervical canal CC can effectively irradiate near-infrared light to the cancer cells C located in the cervical part U. The distal end portion of the optical fiber 60 disposed in the uterine cavity UC can effectively irradiate near-infrared light to the cancer cells C in the cervical region U located in the uterine cavity UC or in the vicinity of the uterine cavity UC. The proximal end portion of the optical fiber 60 disposed in the vagina V can efficiently irradiate near-infrared light to the cancer cells C located in the cervicovaginal region UV and the vagina V.

As described above, the treatment method of the second embodiment is a treatment method of cervical cancer, which has: a step of administering the antibody-light absorbing substance intravenously; inserting a first irradiation instrument 10 having a first optical fiber 60 and a position confirmation mark 50 into a uterine artery UA 12 to 36 hours after intravenous administration; a step of confirming the position of the first irradiation instrument 10 by using the position confirmation mark 50 and advancing the irradiation instrument 10 toward the target position; irradiating near-infrared light in a direction substantially perpendicular to the first optical fiber 60 by using the first optical fiber 60; a step of pulling out the first irradiation instrument 10 from the body; a step of inserting the first irradiation apparatus 10 or a second irradiation apparatus 10 as another irradiation apparatus 10 into the cervical part U from the vagina V; a step of inflating the balloon 30 of the second irradiation device 10 so as to follow the shape of the organ; irradiating the near-infrared light with the second optical fiber 60 in a direction substantially toward the distal end and/or in a direction substantially perpendicular to the second optical fiber 60; a step of deflating the balloon 30.

In the treatment method configured as described above, the first irradiation instrument 10 is inserted into the uterine artery UA and near-infrared light is irradiated from the inside of the blood vessel in a substantially vertical direction, and therefore, near-infrared light can be effectively irradiated to the tissue or organ infiltrated with the cancer cells C in the vicinity of the uterine artery UA. In the treatment method, the irradiation instrument 10 is inserted into the small cervical part U, the balloon 30 is inflated, and the near-infrared light is irradiated in the distal direction and/or the vertical direction, so that the near-infrared light can be effectively irradiated to a wide range of cervical cancer in the cervical part U. Therefore, the treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membranes of the cancer cells C at the cervical region U and the infiltrated pelvic wall. The treatment method is effective not only in the early stage when cancer cells C are localized in the cervical region, but also in stage IIB when cancer cells C infiltrate into the parauterine tissue, stage IIIA when the infiltration of the vaginal wall reaches 1/3 of the lower part of the vagina, stage IIIB when infiltration into the parauterine tissue reaches the pelvic wall, and stage IVA when cancer cells C infiltrate into the urinary bladder and rectal mucosa.

In the second embodiment, the therapeutic device may not be inserted into the blood vessel. That is, a modification of the treatment method of the second embodiment is a treatment method for cervical cancer, which comprises: a step of administering the antibody-light absorbing substance intravenously; inserting the irradiation instrument 10 having the second optical fiber 60 into the cervical part U from the vagina V after 12 to 36 hours from the intravenous administration; a step of inflating the balloon 30 of the irradiation instrument 10 so as to follow the shape of the organ; irradiating near-infrared light in a direction substantially toward the distal end of the optical fiber 60 and/or in a direction substantially perpendicular to the optical fiber 60; a step of deflating the balloon 30.

In the step of inflating the balloon 30 as the deformation portion in the treatment method, a part of the balloon 30 may be inflated so as to follow the shape of the cervicovaginal region UV on the base end side of the external cervical os O. The front end of the balloon 30 may be located in the cervical region U or in the uterine cavity UC. Thus, the treatment method can effectively irradiate the near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cervical part U including the cervical and vaginal UV and the cancer cells of the tissues and organs infiltrating below the cervical part U.

In the step of inflating the balloon 30 as the deformation portion in the treatment method, the proximal end portion of the balloon 30 may be inflated so as to follow the shape of the cervicovaginal region UV on the proximal side of the external cervical os O, and the distal end portion of the balloon 30 may be inflated so as to follow the shape of the uterine cavity UC on the distal side of the internal cervical os I. Therefore, the treatment method can effectively irradiate the near infrared light to the antibody-photosensitive substance combined with the cell membranes of the cervical part U and the cancer cells of tissues and organs infiltrated from the cervical part U in the vertical direction.

The present invention is not limited to the above-described embodiments, and those skilled in the art can make various modifications within the technical spirit of the present invention. For example, as in the first modification of the irradiation instrument 10 shown in fig. 7 (a), the irradiation portion 61 of the optical fiber 60 may be disposed on the outer surface side of the balloon 30 instead of in the balloon 30. The number of the optical fibers 60 may be 1, or 2 or more. This can shorten the distance from the irradiation portion 61 to the cancer cell C, thereby reducing the loss of light energy and allowing near-infrared light to efficiently reach the cancer cell C. Unlike the balloon 30, the optical fiber 60 has no stretchability. Therefore, as shown in fig. 7 (B), the optical fiber 60 is preferably provided in a meandering or spiral shape so as to be deformable following the expansion and contraction balloon 30.

For example, as in the second modification of the irradiation apparatus 10 shown in fig. 8 (a), the deformed portion may be at least 1 wire 31 instead of the balloon 30. The tip end portion of the wire 31 is fixed to the inner tube 22, and the base end portion of the wire 31 is fixed to the outer tube 21, but in the second modification, the inner tube 22 and the outer tube 21 are relatively movable in the axial direction. Therefore, by bringing the front end of the inner tube 22 and the front end of the outer tube 21 closer together in the axial direction, the respective wires 31 receive a compressive force and can be deformed so as to project outward in the radial direction, as shown in fig. 8 (B). The irradiation portion 61 of the optical fiber 60 is disposed on the outer surface of each wire 31. Therefore, the distance from the irradiation portion 61 to the cancer cell C can be shortened, and thus the loss of light energy can be reduced, and near-infrared light can efficiently reach the cancer cell C.

For example, as in the third modification of the irradiation instrument 10 shown in fig. 9 (a), the modification unit may be the balloon 30, and the optical fiber 60 may include an inner optical fiber 62 disposed inside the balloon 30 and an outer optical fiber 63 disposed on the outer surface of the balloon 30. The inner fiber 62 irradiates near-infrared light in a direction substantially toward the distal end, for example. The outer fiber 63 irradiates near infrared light to a range including a direction perpendicular to the axis of the outer fiber 63 and a distal end direction. This can shorten the distance from the irradiation portion 61 of the outer optical fiber 63 to the cancer cell C, thereby reducing the loss of optical energy and allowing near-infrared light to efficiently reach the cancer cell C. Further, the distal end direction can be effectively irradiated with light through the inner fiber 62. The outer optical fiber 63 has no stretchability unlike the balloon 30. Therefore, as shown in fig. 9 (B), the outer optical fiber 63 is preferably provided in a meandering or spiral shape so as to be deformable following the expansion and contraction balloon 30.

It should be noted that the present application is based on japanese laid-open application No. 2019-180489 filed in japan on 30/9/2019, and the disclosure thereof is referred to and incorporated in its entirety into the present application.

Drawings

10: an irradiation instrument; 30: a balloon (deformation portion); 31: a wire (deformation portion); 50: a position confirmation mark; 60: an optical fiber; 61: an irradiation unit; 62: an inner optical fiber; 63: an outer optical fiber; c: cancer cells; CC: a cervical canal; i: the internal os of the cervix; o: the external os of the cervix; UA: uterine artery; u: the cervical part of the uterus; UC: a uterine cavity; UV: a cervicovaginal portion; v: the vagina.

Claims

1. An irradiation instrument for treating cervical cancer, comprising:

a long shaft part,

An expandable balloon provided at the distal end of the shaft portion,

An optical fiber, and

an irradiation unit which is provided at the distal end of the optical fiber and is disposed inside the balloon and can irradiate light,

the irradiation unit may irradiate light in a direction substantially perpendicular to an axis of the optical fiber and in a substantially distal direction.

2. The irradiation apparatus according to claim 1, wherein the irradiation portion irradiates light in a contracted state and an expanded state of the balloon.

3. The irradiation apparatus according to claim 1 or 2, wherein an X-ray opaque position confirmation mark is provided inside said balloon.

4. The illuminating instrument of claim 3, wherein the position confirmation marker has a light accumulating structure, a fluorescent structure, or a light transmitting structure.

5. A method of treatment for cervical cancer, which method comprises:

a step of administering the antibody-light absorbing substance intravenously;

inserting a first irradiation instrument having a first optical fiber and a position confirmation mark into a uterine artery 12 to 36 hours after the intravenous administration;

confirming the position of the first irradiation instrument by using the position confirmation mark and advancing the first irradiation instrument to a target position;

irradiating near-infrared light in a direction substantially perpendicular to the first optical fiber by using the first optical fiber;

a step of pulling out the first irradiation instrument from the body;

a step of inserting the first irradiation instrument or a second irradiation instrument as another irradiation instrument into the cervical part from the vagina;

irradiating the second optical fiber of the second irradiation instrument in a direction substantially perpendicular to the second optical fiber;

a step of pulling out at least a part of a deformed portion of the second irradiation instrument to the external cervical os to expand the deformed portion so as to follow the shape of the organ;

irradiating near-infrared light in a direction substantially toward the distal end of the second optical fiber and/or in a direction substantially perpendicular to the second optical fiber;

and contracting the deformation portion.

6. A method for treating cervical cancer, which comprises:

a step of administering the antibody-light absorbing substance intravenously;

a step of pulling out the first irradiation instrument from the body;

expanding a deformation portion of the second irradiation instrument so as to follow a shape of an organ;

irradiating near-infrared light in a direction substantially perpendicular to the second optical fiber and/or in a direction substantially perpendicular to the second optical fiber by using the second optical fiber;

and contracting the deformation portion.

7. A method for treating cervical cancer, which comprises:

a step of administering the antibody-light absorbing substance intravenously;

inserting a second irradiation device having a second optical fiber into the cervical region from the vagina after 12 to 36 hours from the intravenous administration;

and contracting the deformation portion.

8. A method for treating cervical cancer, which comprises:

a step of administering the antibody-light absorbing substance intravenously;

a step of expanding the deformed portion of the second irradiation instrument so as to follow the shape of the organ;

and contracting the deformation portion.

9. The treatment method according to claim 8, wherein in the step of expanding the deformation portion, a part of the deformation portion is expanded so as to follow a shape of the cervicovaginal portion on a base end side with respect to the external cervical os.

10. The method according to claim 8, wherein in the step of expanding the deformation portion, a proximal end portion of the deformation portion is expanded so as to follow a shape of the cervicovaginal portion on a proximal side with respect to an external cervical os, and a distal end portion of the deformation portion is expanded so as to follow a shape of the uterine cavity on a distal side with respect to an internal cervical os.

11. The treatment method of any one of claims 1 to 10, wherein after the step of contracting the deformation, the following steps are repeated at least 1 time: rotating the second irradiating device; expanding the deformation portion so as to follow the shape of the organ; irradiating near-infrared light in a direction toward a front end and/or a direction perpendicular to the second optical fiber by using the second optical fiber; and contracting the deformation portion.

12. The method according to any one of claims 1 to 11, wherein when the second irradiation device is inserted into the cervix from the vagina or when the second irradiation device is pulled out from the cervix to the vagina, the position of the second irradiation device is confirmed in the cervix by observing increase and decrease of light emitted from a portion of the second irradiation device that can be inserted into the cervix from the vagina side.

13. The treatment method of claim 1 or 2 wherein the second irradiating device is the same device as the first irradiating device.

14. The method of claim 1, 2 or 13, wherein the step of removing the first irradiation instrument from the body is followed by washing the first irradiation instrument.

15. The treatment method of claim 1, 2, 13 or 14, wherein there is:

expanding a deformed portion of the first irradiation instrument before the step of irradiating near-infrared light with the first optical fiber;

and a step of contracting the deformed portion of the first irradiation instrument after the step of irradiating near-infrared light with the first optical fiber.